跳至主要内容
临床试验/NCT03972969
NCT03972969已完成不适用

Highly Challenging Balance Program to Reduce Fall Rate in PD

VA Office of Research and Development1 个研究点 分布在 1 个国家目标入组 162 人开始时间: 2019年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
162
试验地点
1
主要终点
Number of Falls Over 3 Month Period

研究概览

简要总结

This study will test the hypothesis that two highly challenging exercise programs, one based at the VA medical center and the other conducted remotely, will both significantly reduce overall fall rates in patients with Parkinson's disease.

详细描述

Background/Rationale. Parkinson's disease (PD) is the second most common neurodegenerative disease, affecting over one million Americans. The cardinal clinical manifestations of PD include resting tremor, rigidity, bradykinesia, and postural instability/gait disturbance. In addition, people with PD fall frequently, with 60% falling annually and two-thirds of these falling recurrently. Identifying interventions that successfully improve postural control and reduce fall rate is critical to reduce disability, improve quality of life, and potentially increase survival in patients with PD. Recent randomized, controlled trials (RCT) have examined the effects of exercise and physical therapy interventions on reducing falls in patients with PD; however, with mixed results.

Objectives. There is a limited availability of effective treatment options to reduce falls in PD. In this context, some studies suggest that highly challenging exercise approaches may lead to better outcomes. The investigators propose investigating the effects of two theoretically driven, progressive, highly challenging exercise programs: 1) a structured exercise program at the VA and 2) a structured exercise program at home. There will also be a control group in which health education is provided.

Methods. The investigators propose to conduct an RCT evaluating effects on fall rate. A total of 162 VA patients with mild-to-moderate PD will be randomly assigned to one of the three 3-month interventions: in-person exercise at the VA, remotely-delivered exercise, or health education. Outcomes will be compared between each intervention group and the control group. Fall rates will be compared between groups with the use of negative binomial regression models.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
40 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Physician diagnosis of idiopathic PD
  • •At least 2 of the 3 cardinal signs of PD (resting tremor, rigidity, bradykinesia)
  • •Response to dopaminergic medication

排除标准

  • •Angina pectoris
  • •History of myocardial infarction (MI) within 6 months
  • •History of ventricular dysrhythmia requiring current therapy

研究组 & 干预措施

In-person exercise group

Experimental

facility-based structured exercise program

干预措施: Facility-based structured exercise (Behavioral)

Remote exercise group

Experimental

home-based structured exercise program

干预措施: Home-based structured exercise (Behavioral)

Control group

Active Comparator

health education

干预措施: Health education (Behavioral)

结局指标

主要结局

Number of Falls Over 3 Month Period

时间窗: Baseline to 3 months

Total number of falls from baseline to the 3-month follow-up. Falls are defined as unexpected events in which the participants come to rest on the ground, floor, or lower level.

次要结局

  • Number of Falls Over 6 Month Period(Baseline to 6 months)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验